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Clinical Trials in Sweden / NCT07524426
Recruiting Not applicable

Local Radiotherapy for Urinary Bladder Cancer in Patients Not Eligible for Curative Treatment

NCT07524426 · tracked via the Priya Life Science Sweden tracker
Sponsor
Umeå University
Phase
Not applicable
Started
2026-06-03
Last updated
2026-06-09

Condition(s) studied

Bladder Cancer (BC)

Investigational drug(s) / intervention(s)

Local hypo fractionated adaptive radiotherapy and Standard of CareStandard of Care (Investigator Choice)

Local hypo fractionated adaptive radiotherapy and Standard of Care: Patients randomized to the radiotherapy (RT) arm will receive external beam radiotherapy to the whole urinary bladder as well as Standard of Care. Intensity-modulated Radiotherapy will be delivered using an adaptive treatment strategy, permitting either: * Plan-of-the-day (PoD) adaptive radiotherapy using a predefined library of plans, or * Online adaptive radiotherapy (oART) with daily re-contouring and re-optimisation to the anatomy of the day. The choice of adaptive strategy (PoD vs oART) and imaging modality (CBCT- or MR-based) is at institutional discretion, provided all protocol-specified target coverage objectives and organ-at-risk (OAR) constraints are met. The prescribed dose is 21 Gy in 3 fractions of 7 Gy, delivered every other day.

Standard of Care (Investigator Choice): All applicable palliative treatments associated with the Standard of Care, such as local RT, TURB, systemic anti-tumour treatments or other interventions/treatments applicable according to treating physician are allowed

Study summary

The goal of this clinical trial is to improve the quality of life and prolong survival in bladder cancer patients unfit for curative treatment. The trial will compare the survival and symptoms of patients randomized to either local radiotherapy in addition to standard of care or standard of care alone.

Using modern radiotherapy techniques, including hypofractionation and image-guided treatment adaptation, the aim is to deliver a well-tolerated, time-efficient, and effective treatment strategy for these patients.

The trial collaborates with two ongoing exploratory biomarker studies collecting and analyzing potential biomarkers in urothelial bladder cancer. The hope is to provide biomarkers for prognosis and treatment response which is essential to ensure bladder cancer patients individualized treatment in the future, like those with breast and prostate cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Oral and written consent 2. Histologically confirmed MIBC with urothelial component 3. Male or female participants ≥ 18 years old 4. Deemed not to benefit from curative treatment at a multidisciplinary tumour conference (MDT) or having declined curative treatment of their own accord. Exclusion Criteria: 1. Clinical Fragility Scale score ≥8 2. Previous pelvic RT with significant overlap 3. Visceral or bone metastases on CT scan 4. Multiple (\>3) lymph node metastases with a measurement of \>2 cm on CT scan 5. Planed for systemic treatment at the time of inclusion. 6. Local RT to the bladder indicated for the palliation of symptoms at the time of inclusion.

Primary outcome measure(s)

  • Overall Survival — From date of randomization until the date of death from any cause assessed up to a minimum of 36 months

Trial sites (1)

FacilityCityRegionStatus
Norrlands University Hosital Umeå Västerbotten County Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07524426 on ClinicalTrials.gov ↗ ← All trials in Sweden